The Effect of Tubal Ligation, Essure Placement, AND Levonorgestrel Intrauterine Device on Serum Anti-Mullerian Hormone Rates Over Time
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Serum anti-Mullerian hormone levels
研究概览
简要总结
Anti-mullerian hormone (AMH) has been shown to be a reliable marker of ovarian reserve. In prior studies, tubal ligation has been shown to have an adverse effect on ovarian reserve. One theory postulated for this effect is that the ovarian circulation is disrupted by the procedure, leading to altered hormone production. In this prospective cohort study, the investigators plan to analyze the rates of AMH decline by comparing the following contraceptive methods: tubal ligation, Essure placement, and levonorgestrel intrauterine devices (IUDs).
详细描述
Anti-mullerian hormone (AMH) has been shown to be a reliable marker of ovarian reserve because levels demonstrate a consistent age-related decline and do not fluctuate throughout the menstrual cycle. In prior studies measuring markers other than AMH, tubal ligation has been shown to have an adverse effect on ovarian reserve.
The primary aim of this study will be to compare the rates of anti-mullerian hormone (AMH) decline following tubal ligation, Essure placement, and levonorgestrel IUDs, and then identifying any and all differences that these specific contraceptive methods have on the changes of AMH rates over time. The secondary aim will focus on analyzing the various types of tubal ligation methods (i.e. coagulation, ligation, clips, bands, etc.) to see if different techniques result in any difference in the rate of AMH decline. The hypothesis is that tubal ligation will result in an accelerated rate of AMH decline as compared to other long-term or permanent contraceptive methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Age 25-40
- •Electing one of the following contraceptive methods: tubal ligation, Essure, levonorgestrel IUD
- •Ability to understand study procedures and to comply with them for the entire length of the study
- •Willingness to comply with follow-up visit requirements
排除标准
- •Age <25 or >40 at initiation or completion of the study
- •Prior oophorectomy or salpingectomy
- •Prior surgery of the ovaries or fallopian tubes
- •Prior ovarian, uterine, or fallopian tube cancers
- •Prior ovarian, uterine, or fallopian tube radiation exceeding >200rads
- •Prior platinum-based or alkalizing chemotherapy
- •Current cancer (any form)
- •Current pregnancy
- •Allergy to any of the components of the selected devices (titanium, rubber, nickel, plastic, silicone)
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- •Inability or unwillingness of a potential participant to give written informed consent
- •Inability for the potential participant to consent for herself
结局指标
主要结局
Serum anti-Mullerian hormone levels
时间窗: 24 months
1 blood draw prior to procedure; four more blood draws at 6-month intervals
次要结局
未报告次要终点